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临床试验/NCT06588036
NCT06588036尚未招募早期 1 期

A Comprehensive Analysis of the Comparative Efficacy of Multimodal Diarrhea Therapies

Combined Military Hospital Multan0 个研究点目标入组 100 人开始时间: 2024年9月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
尚未招募
发起方
入组人数
100
主要终点
resolution of diarrhea

研究概览

简要总结

The objective of this research is to assess the mean time of resolution of diarrhea in pediatric patients receiving different intervention combinations for the management of acute diarrhea. Specifically, the study aims to compare the effectiveness of four intervention groups: Group 1 receiving zinc and probiotic supplementation, Group 2 receiving zinc, probiotic, and prebiotics. Group 3 receiving zinc, probiotics, and anti-secretory agents, and Group 4 receiving zinc, probiotic, anti-secretory agents, and adsorbents. The primary outcome measure will be the mean time from the initiation of treatment to the resolution of diarrhea symptoms. This objective seeks to provide evidence-based insights into the optimal management strategies for childhood diarrhea and inform clinical practice guidelines.

详细描述

This study will employ a randomized controlled trial (RCT) design and will be conducted at the Combined Military Hospital (CMH) in Multan, Pakistan, from September 15, 2024, to December 15, 2024. A total of 100 patients will be included, with approximately 25 patients allocated to each intervention group. The sampling technique will be convenience sampling, where patients meeting the inclusion criteria and presenting during the study period will be recruited.

The main study variables include the intervention groups-Group 1: zinc and probiotic, Group 2: zinc, probiotic, and prebiotics, Group 3: zinc, probiotics, and anti-secretory, and Group 4: zinc, probiotic, anti-secretory, and adsorbent-time to resolution of diarrhea, and clinical outcomes. Data will be collected through caregiver interviews, clinical examinations, and a review of medical records. A structured questionnaire or proforma will be used to gather relevant information from patients and caregivers regarding demographic characteristics, clinical presentation, interventions received, and outcomes.

**Data Analysis Procedure:** Statistical analysis will be conducted using SPSS software, version 28.0 (IBM Corp., Armonk, NY). Both quantitative and qualitative data will be analyzed, with descriptive statistics such as mean, median, standard deviation, and frequency distributions used to summarize the demographic and clinical characteristics of the study population. For comparing outcomes between intervention groups, inferential statistical tests such as ANOVA for continuous variables and the Chi-square test for categorical variables will be employed, depending on the nature of the data. Confounding variables will be controlled through multivariate analysis, and a p-value of less than 0.05 will be considered statistically significant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Care Provider)

入排标准

年龄范围
6 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria:
  • Pediatric patients, both male and female, aged 6 months to 5 years presenting with acute diarrhea at CMH Multan.
  • Patients or caregivers willing to provide informed consent for participation in the study.

排除标准

  • Pediatric Patients with chronic diarrhea or underlying gastrointestinal disorders.
  • Pediatric Patients with severe dehydration requiring immediate medical intervention.
  • Pediatric Patients with a history of allergy or intolerance to any of the study interventions.
  • Pediatric Patients with severe comorbidities or immunocompromised status.

研究组 & 干预措施

Intervention Group

Active Comparator

: Group 1 receiving zinc and probiotic supplementation, Group 2 receiving zinc, probiotic, and prebiotics. Group 3 receiving zinc, probiotics, and anti-secretory agents, and Group 4 receiving zinc, probiotic, anti-secretory agents, and adsorbents.

干预措施: Prebiotic (Drug)

Intervention Group

Active Comparator

: Group 1 receiving zinc and probiotic supplementation, Group 2 receiving zinc, probiotic, and prebiotics. Group 3 receiving zinc, probiotics, and anti-secretory agents, and Group 4 receiving zinc, probiotic, anti-secretory agents, and adsorbents.

干预措施: Duration (Other)

Duration of diarrhea

Active Comparator

This will showcase the duration of diarrhea that the pediatric population had before receiving treatment.

干预措施: Prebiotic (Drug)

Duration of diarrhea

Active Comparator

This will showcase the duration of diarrhea that the pediatric population had before receiving treatment.

干预措施: Smecta (Drug)

结局指标

主要结局

resolution of diarrhea

时间窗: 3 months

mean time of resolution of diarrhea in different intervention groups

次要结局

未报告次要终点

研究者

发起方
Combined Military Hospital Multan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aamir Aslam Awan

Assistant Professor

Combined Military Hospital Multan

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